Osteopathic Manipulative Treatment in Chronic Non-specific Neck Pain

June 2, 2020 updated by: Şule

Osteopathic Manipulative Treatment in Chronic Non-specific Neck Pain: A Controlled Study

The aim of this study is to investigate the effect of osteopathic manipulative treatment on pain intensity, disability level and psychosocial factors in patients with chronic non-specific neck pain. We hypothesed that osteopathic manipulative treatment is better than conventional physiotherapy in management of pain, disability and depression.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study will conduct between April 2020 and July 2020 at Denizli State Hospital. Participants who were diagnosed as chronic non-specific neck pain by a specialist physician will include the study. They will treated at physical therapy clinic. Inclussion criteria will; participants diagnosed as non-specific neck pain by the physician and Non-spesific neck pain at least 3 months. Exclussion criteria were; participants who have had surgery or are indicated for surgery, participants who have had exercise therapy and / or physical therapy in the last 1 year with a history of trauma to the cervical region, participants who have had neck pain that develop due to a particular cause such as tumor, compression fracture, metastasis and infection. According to power analysis, 102 participant will include the study with 95% coincidence interval and 80% power. Participants will be divided into 2 groups. Randomization method will be closed envelope. Group 1 will receive Conventional Physiotherapy Programme (CP), Group 2 will receive Osteopathin Manipulative Treatment (OMT). Pain Intensity at rest and activity, psychological state( Beck Depression Inventory) and Disability level (Neck Disability Index) will assess at baseline and 3 weeks.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Denizli, Turkey, 20040
        • Denizli State Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • participants diagnosed as non-specific neck pain by the physician.
  • Non-spesific neck pain at least 3 months.

Exclusion Criteria:

  • participants who have had surgery or are indicated for surgery
  • participants who have had exercise therapy and / or physical therapy in the last 1 year with a history of trauma to the cervical region
  • participants who have had neck pains that develop due to a particular cause such as tumor, compression fracture, metastasis and infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Conventional Physiotherapy Group
This group will receive 15 sessions of conventional physiotherapy programme 5 times per week.
Procedure: Conventional Physiotherapy
Conventional Physiotherapy consist of Hotpacks, TENS and US.The participants were positioned in sitting and supported with a pillow under the head, 20 min hot pack was applied. Therapatic Ultrason were applied with the frequency of 1 MHz, intensity of 1,5 watt/cm² and duration of 5 minute. TENS was applied to the cervical region with 2-channel, 4 surface electrodes at 60-120 Hz, and 50-100 pulse duration for 20 minutes.
Experimental: Osteopathic Manipulative Treatment Group
This group will receive 9 sessions of Osteopathic Manipulative Treatment programme 3 times per week.
Procedure: Osteopathic Manupilative Treatment
Osteopathic Manupilative Treatment consist of stretching the fascia to the cervical region, soft tissue mobilization to the surrounding muscles, cervical manual traction, passive joint mobilization to the 7 cervical spine, passive joint mobilization to the 1st costa, passive joint mobilization to the clavicle and passive joint mobilization to the sternum mobilization in supine and prome positions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity
Time Frame: Change from baseline pain intensity at 3 weeks
pain intensity at rest and activity will measure by VAS
Change from baseline pain intensity at 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disability level
Time Frame: Change from baseline Neck Disability Index score at 3 weeks
Disability level will measue by Neck Disability Index. Score ranges from 0-100. Higher score indicates worse outcome.
Change from baseline Neck Disability Index score at 3 weeks
Depression level
Time Frame: Change from baseline Beck Depression Inventory score at 3 weeks
Depression will measure by Beck Depression Inventory. Scores ranges from 0-63. Higher score indicates worse outcome.
Change from baseline Beck Depression Inventory score at 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Şule

Investigators

  • Study Director: Nesrin Yağcı, Prof., Pamukkale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2020

Primary Completion (Anticipated)

September 20, 2020

Study Completion (Anticipated)

December 20, 2020

Study Registration Dates

First Submitted

April 13, 2020

First Submitted That Met QC Criteria

April 18, 2020

First Posted (Actual)

April 21, 2020

Study Record Updates

Last Update Posted (Actual)

June 4, 2020

Last Update Submitted That Met QC Criteria

June 2, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21.05.2019/10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Because there is no web site to share my data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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